Cleared Traditional

K073070 - DIO BIOTITE-H IMPLANT SYSTEM

K073070 is an FDA 510(k) clearance for DIO BIOTITE-H IMPLANT SYSTEM, manufactured by Dio Department Dsi, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K073070 · Dio Department Dsi, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
199d
Days
Class 2
Risk

K073070 is an FDA 510(k) clearance for the DIO BIOTITE-H IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dio Department Dsi, Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on May 16, 2008 after a review of 199 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K073070

510(k) Number K073070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2007
Decision Date May 16, 2008
Days to Decision 199 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 128d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K073070.
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK
K080224 · SOADCO, S.L. · Jul 2008
I-MINI DENTAL IMPLANT
K080115 · Oco Biomedical · May 2008
SECURE IMPLANT SYSTEM (2.5/3.0MM)
K080129 · Dio Department Dsi, Inc. · May 2008
REACTIVE DENTAL IMPLANT SYSTEM
K080713 · Implant Direct, LLC · May 2008
EASY GRIP DENTAL IMPLANT SYSTEM
K073622 · T.F.I. System S.R.L · May 2008
SM-EXTRA WIDE (RBM) IMPLANT SYSTEM
K080128 · Dio Department Dsi, Inc. · May 2008
K073070 · DIO BIOTITE-H IMPLANT SYSTEM
Download PDF FDA Summary Dio Department Dsi, I…